X-Port, ChronoFlex 0605850Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741026010), received between Oct 18, 2019 and Sep 4, 2025 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE LITIGATION PROCESS THAT SOMETIME POST A PORT PLACEMENT, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22961405 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH LITIGATION PROCESS THAT SOMETIME LATER PORT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED WITH UNSPECIFIED INFECTION. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 22587107 ↗
• InjurySep 12, 2024Difficult to Flush; Device Appears to Trigger Rejection; Difficult to Flush; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THERE WAS ALLEGEDLY DIFFICULTY IN FLUSHING THE PORT. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY AN INSTANCE OF MILD INFILTRATION OF INTRAVENOUS FLUIDS. FURTHERMORE, THE PATIENT ALLEGEDLY EXPERIENCED LARGE FIBRIN SHEATH FORMATION AT THE END OF THE PORT AND THE PATIENT WAS TREATED WITH TISSUE PLASMINOGEN ACTIVATOR. REPORTEDLY, THE OUTCOME OF THE ISSUE WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Infiltration into Tissue

  MAUDE report 20198663 ↗
• InjurySep 12, 2024Difficult to Flush; Device Appears to Trigger Rejection; Difficult to Flush; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THERE WAS ALLEGEDLY DIFFICULTY IN FLUSHING THE PORT. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY AN INSTANCE OF MILD INFILTRATION OF INTRAVENOUS FLUIDS. FURTHERMORE, THE PATIENT ALLEGEDLY EXPERIENCED LARGE FIBRIN SHEATH FORMATION AT THE END OF THE PORT AND THE PATIENT WAS TREATED WITH TISSUE PLASMINOGEN ACTIVATOR. REPORTEDLY, THE OUTCOME OF THE ISSUE WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Infiltration into Tissue

  MAUDE report 20198549 ↗
• InjurySep 10, 2024Difficult to Flush; Device Appears to Trigger Rejection; Difficult to Flush; Device Appears to Trigger Rejection

  IT WAS REPORTED THAT SOMETIME POST A PORT PLACEMENT, THERE WAS ALLEGEDLY DIFFICULTY IN FLUSHING THE PORT. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY AN INSTANCE OF MILD INFILTRATION OF INTRAVENOUS FLUIDS. FURTHERMORE, THE PATIENT ALLEGEDLY EXPERIENCED LARGE FIBRIN SHEATH FORMATION AT THE END OF THE PORT AND THE PATIENT WAS TREATED WITH TISSUE PLASMINOGEN ACTIVATOR. REPORTEDLY, THE OUTCOME OF THE ISSUE WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Infiltration into Tissue

  MAUDE report 20180400 ↗
• MalfunctionOct 18, 2019Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL 0605850, IMPLANTABLE PORT, WAS ALLEGEDLY FRACTURED DURING TUNNELING. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9208950 ↗